1. Field of Invention
The present invention generally relates to an improved system and method for supporting endotracheal and like medical tubing in pediatric patients, and more particularly a system and method of achieving the same without causing palatal groove formation, acquired cleft palate, defective primary dentition or oral infection during prolonged intubation.
2. Brief Description of the Prior Art
Typically, infants suffering from respiratory failure require mechanically-assisted ventilation. In general, the delivery of gases to the lungs of such infants is achieved through an endotracheal tube. According to convention, one end of the endotracheal tube extends through the mouth and trachea of the infant, while the other end is connected to a mechanical ventilator. Often, artificial ventilation of such infants is conducted for days and sometimes weeks and months until the premature infant's respiratory capacity is sufficiently developed to be safely removed from the artificial ventilator. During the entire intubation period, the endotracheal tube is retained within the trachea and oral cavity of the infant.
It has been known for some time that prolonged intubation using the endotracheal tube can cause a palatal groove which, by definition, is an architectural deformity of the palate caused by constant external pressure on the palatal surface by the endotracheal tube. Studies have shown that the incidence of palatal groove formation increases with the increasing duration of intubation. Studies have also shown that infants who have been intubated for prolonged time periods, typically exhibit poor speech intelligibility, cross bite formation, and high dental vaults later in childhood, and speculate that the palatal groove itself may have an effect on poor phonation and disturbed dental positioning.
Studies also indicate that prolonged intubation may cause complications to the maxillary alveolar ridge, development of a cleft palate, and defective primary dentition due to the constant pressure of the tube in the oral cavity, and tracheal mucosal damage.
Hitherto, a number of prior art intraoral appliances and methods of making and using the same have been developed in order to stabilize endotracheal tubes on the palate, while attempting to prevent the formation of palatal groove and decrease damage to the airway mucosa and vocal cords, and the potential for accidental extubation and defective dentition. Such prior art activity is described in the following publications: "An Intraoral Appliance to Stabilize Orogastric Tubes in Premature Infants, by P. G. Sullivan published in Volume 1 of Lancet, pages 416-147, 1981; "An Appliance to Support oral Intubation in the Premature Infant: by P. G. Sullivan published in Volume 152, Number 6 of the British Dental Journal, pages 191-194, Mar. 16, 1982; An intraoral Prosthetic Appliance for the Prevention of Palatal Grooving in Premature Intubated Infants," by Shahrbanoo Fadavi, et al., published in Volume 12, No. 1, Clinical Preventative Dentistry, at pages 9-12, April-May 1990; "Use of a Palatal Stabilizing Device in the Prevention of Palatal Grooves in Premature Infants" by Shahrbanoo Fadavi, et al., published in Volume 18, No. 11, of Critical Care Medicine, at pages 1279-1281, November, 1990; and United States Letters Patent No. 5,195,53 to Sinko, et al., entitled "Infant Palate Protective Prosthesis" issued on Mar. 23, 1993.
In general, each of these prior art references discloses a method of making a custom-fitted device for use in the mouth of a premature infant. The base plate of each custom-made device has a surface which is particularly fitted to the palate of a particular infant by way of suction forces and dental powder. The base plate also has a longitudinally extending bore, along which the endotracheal tube is supported in a stabilized manner to prevent extubation. The custom-fitted base plate is made from rubber or soft plastic material designed to attenuate the constant pressure applied to the palate by the endotracheal tube during prolonged periods of intubation.
While the above described intraoral devices have reduced the possibility of groove formation associated with prolonged intubation using endotracheal tubes, such prior art devices and techniques suffer from a number of shortcomings and drawbacks.
In particular, prior art techniques for secure fixation of the endotracheal tube require the tight application of tape across the midface which, in turn, prevents the growth of this region resulting in maxillo facial hypoplasia.
Prior art devices require custom fitting and manufacture prior to use. This necessitates taking an impression of each infant's palate using a soft material in order to make a custom mold, and then making the device using the mold. This procedure often disturbs the infant, adds to the cost of using this tube stabilizing technique, and otherwise complicates matters in critical and intensive care units for neonatal care.
Often, the above-described prior art device fails to provide adequate protection to the alveolar ridge and lips of premature infants subject to prolonged intubation using endotracheal tubes. In addition, the custom fitted base plate is required to fit snugly to the infant's palate, creates a condition where bacteria can become entrapped and not easily removed without disrupting intubation. Thus by making it difficult to maintain oral hygiene, use of such prior art devices also increases the risk of oral infection.
Thus there is a great need in the art for an improved device for stabilizing endotracheal tubes and a method of using the same, without the accompanying shortcomings and drawbacks of prior art apparatus and methodologies.